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K Number
K092450
Device Name
HUMAN IGD KIT FOR USE ON SPAPLUS
Manufacturer
THE BINDING SITE
Date Cleared
2009-12-28

(140 days)

Product Code
CZJ
Regulation Number
866.5510
Type
Traditional
Panel
IM
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

This kit is intended for measuring human immunoglobulin D (IgD) in serum as an aid in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents. The test result is to be used in conjunction with other clinical and laboratory findings.

Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text only contains an FDA clearance letter for a medical device (Human IgD Kit for use on SPAplus). It does not include information about acceptance criteria, device performance results, study details, or ground truth establishment. Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on this input.

§ 866.5510 Immunoglobulins A, G, M, D, and E immunological test system.

(a)
Identification. An immunoglobulins A, G, M, D, and E immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the immunoglobulins A, G, M, D, an E (serum antibodies) in serum. Measurement of these immunoglobulins aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents.(b)
Classification. Class II (performance standards).